Spots Global Cancer Trial Database for Radiotherapy With Neoadjuvant Chemotherapy and Immunotherapy in Rectal Cancer
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Trial Identification
Brief Title: Radiotherapy With Neoadjuvant Chemotherapy and Immunotherapy in Rectal Cancer
Official Title: Short Course Radiotherapy With Total Neoadjuvant Chemotherapy and Immunotherapy in Rectal Cancer
Study ID: NCT04558684
Study Description
Brief Summary: This is a open-label, single-arm study to investigate the safety and efficacy of Total neoadjuvant chemotherapy with camrelizumab, an anti-PD-1 antibody drug following short course radiotherapy in patients with rectal cancer.
Detailed Description: Patients with rectal cancer are assigned to receive preoperative 5 × 5 Gy irradiation over 5 days with total neoadjuvant chemotherapy and camrelizumab, an anti-PD-1 antibody drug. The Primary Objective is to assess clinical complete response of an organ preservation approach and the secondary objective to assess safety in all enrolled patients, local regrowth rate and other cancer specific outcomes (metastasis-free survival, colostomy-free survival and overall survival), longitudinal health-related quality of life of this organ preservation approach.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
Contact Details
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